Scalp Cooling to Prevent Chemo-induced Hair Loss

Not Applicable

Interventions: Device: PAXMAN Orbis Scalp Cooler
Other: Control No treatment

Brief Summary: Determine that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.

Detailed Description: Cooling the scalp during chemotherapy may help reduce the chances of losing hair during treatment. The investigators are hoping that using the PAXMAN Orbis Scalp Cooling Device may stop patients who are undergoing chemotherapy from losing their hair.

Recruitment & Eligibility

Inclusion Criteria

New diagnosis of breast cancer stage 1-2
Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent
Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline or taxane based chemotherapy regimen,
Defined as one of the following regimens: - Adriamycin 60mg/m2 with cyclophosphamide 600mg/m2 - Epirubicin 90-100mg/m2 with cyclophosphamide 600mg/m2 - Doxorubicin 50mg/m2 with 5-Fluroruacil 500mg/m2 and Cyclophosphamide 500mg/m2 - Paclitaxel 80mg-90/m2 weekly (every three weeks constitute a cycle), or 175 mg/m2 every 2-3 weeks as a single agent - Docetaxel 100mg/m2 as a single agent - Docetaxel 75mg/m2-100mg/m2 with pertuzumab and traztuzumab at standard doses - Docetaxel 75mg/m2 with cyclophosphamide 600mg/m2 - Docetaxel 75mg/m2 with carboplatin AUC of 6 and trastuzumab at standard doses
Concurrent traztuzumab at standard doses is allowed
Concurrent pertuzumab at standard doses is allowed
Administration of chemotherapy on a dose dense schedule is allowed as clinically indicated.
Subjects must have TSH collected within 1 year prior to treatment and found within normal range.
If patient has a history of diabetes, Hemoglobin A1c must be drawn within 3 months prior to treatment and found to be within normal limits.
CBC and CMP should be done within 4 weeks prior to treatment and found to be within acceptable limits.

Exclusion Criteria

Stage 3 or 4 breast cancer or any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)
Baseline alopecia (defined CTCAE v4.0 grade > 0, see appendix B for CTCAE v4.0 scale)
Subjects with cold agglutinin disease or cold urticaria
Subjects who are scheduled for bone marrow ablation chemotherapy
Subjects receiving chemotherapy with concurrent anthracycline and taxane (AT or TAC)
Male gender
Age >= 70 years

Arm && Interventions

Group	Intervention	Description
PAXMAN Orbis Scalp Cooler	PAXMAN Orbis Scalp Cooler	Scalp Cooling
Control No treatment	Control No treatment	Control

Primary Outcome Measures

Name	Time	Method
Hair Preservation	4 to 8 Months	The primary efficacy endpoint will be success in hair preservation, defined as CTCAE v 4 alopecia grade \<2, and will be assessed by a healthcare professional who is blinded to study treatment.

Secondary Outcome Measures

Name	Time	Method
Time to First Recurrence and Overall Survival	5 years	A safety follow-up for safety data will be done yearly for 5 years looking at time to first recurrence of breast cancer, overall survival, site of first recurrence, and incidence of isolated scalp metastasis. This will be collected during routine clinical observation

Locations (7): Hematology & Oncology Associates of Northern New Jersey
🇺🇸
Morristown, New Jersey, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Texas Oncology - Medical City Dallas
🇺🇸
Dallas, Texas, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
🇺🇸
Dallas, Texas, United States
USOncology / Texas Oncology-Memorial City
🇺🇸
Houston, Texas, United States
Lester and Sue Smith Breast Center at Baylor College of Medicine
🇺🇸
Houston, Texas, United States